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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Headache (1880); Visual Impairment (2138); Depression (2361)
Event Type  No Answer Provided  
Event Description
I had lasik done 6 months ago. The outcome has changed my life forever. I now have terrible night vision, which now includes huge starburst and glare. My eyes really aren't dry, so i guess i dodged that bullet. The worst thing about it is that fixing my night vision problems would now require a hard rigid lenses designed custom made for my eyes, which may not even fix my problems. Before i had perfect vision with contact lenses. What a terrible mistake i have made. I am only (b)(6) and now for the rest of my life i have to right this devastating condition. Why is lasik even legal, why was i not told directly by the doctors that my large pupil would cause poor night vision. I would give every dime to my name to get my old crappy eyes back that were fixed perfectly with contact lenses. I have considered suicide on several occasions. I have never ever been suicidal my entire life. I am now on antidepressants which i know is the only reason i am here today explaining my struggle. I can no longer enjoy my night outs with my friends, i can't go anywhere at night without a horrible headache from trying to see. I pray and pray that they will find a way to cure this condition. Please shut down lasik.
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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key4024257
Report NumberMW5037734
Device Sequence Number1
Product Code LZS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Patient Age22 YR
Patient Outcome(s) Disability;